Happy New Year!
A few hours before the end of the comment period, I submitted my comments to FDA’s docket on Regulations.gov for the new NDC format. By the time your read this, the docket will be closed. The agency that operates that web site often takes a few days to post submissions, but because of the government shutdown, I doubt if anyone will be working on it until after the government re-opens (assuming the furloughed workers haven’t gotten a better job by then…In that case, it could be even longer).
Since it could take a long time before you can see the submitted responses through Regulations.gov, here is my submission.
Basically, I only have three things to say to the FDA regarding the new format of the National Drug Code (NDC), and only the first of those is critically important. That is, it is critically important that the new format of the NDC result in a single identifier for each drug package. That’s it. Nothing else is critically important (see also “An Open Letter To The FDA: New NDC Format Public Meeting” and “FDA New NDC Format Public Meeting“). I provided one of probably several ways to accomplish this so they could see that it is possible, but there are probably multiple other ways to do it. I also provided some of my thoughts on the timing of the change.
Once all of the submissions become available I will provide an overview of those that contain significant ideas–good or bad, in my view. Watch for that!